Scientist II, Manufacturing Sciences

Thermo Fisher Scientific•Cincinnati, OH

About The Position

As a Manufacturing Scientist II, you will lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms. Project management skills will be applied to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities. This will require the writing, approval, and routing documents within a manufacturing setting. You will be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations. Investigates, creates, and validates new scientific and equipment methodologies for a diverse scope of projects. Using experimental design, established formulation processes for the following phases of product scale-up, registration, and validation. Creates processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Leads problem solving activities as necessary with independent judgement. Makes decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems. Coaching Scientist I and Scientist II’s will be required to provide guidance on assigned projects. Specific coaching in the areas of project pathways as projects may require selecting proper excipients, equipment, and process parameters on a supervisory level. Communicates up and down the internal management track to provide accurate and detailed progress of projects that focuses on timely completion of activities and critical turning points. Time bound outlines to complete activities for the validation of new products and manufacturing processes of solids, liquids, and semi-solid dosage forms. Leverage current leadership skills to provide support, mentoring and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas. Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations. Own the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements. Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies. Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches. Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility. Lead with project leadership skill required for daily meetings Work independently within the Technical Services Department and work as team member within the department Managing work independently with standard work planning and abilities to meet timelines established for projects. Proficiencies of Leadership, Trust, Diversity and Focused behaviors are required for the position. Quality attitude to be exemplified daily with standard work. Outstanding team dynamics and idea generation is promoted.

Requirements

Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required.
Minimum of one (1) to three (3) years of experience in a manufacturing environment preferred
Understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
Lead projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations.
Proficiency using Microsoft (MS) Office applications.
Good critical and logical thinking skills.
Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
Self-starter, mature, independent, and detailed oriented.
Ability to work in a fast-paced, results oriented, and structured environment.
Experience leading projects related to process development including scale-up production activities.
Effective time management, multi-tasking and prioritization skills to effectively run multiple projects.
Lead by example.
Courages and assumes challenges in a risk based approaches.
Transparent and knowledgeable in presenting project updates daily.
Diligent in team meetings and discussions.
Collaborate across multiple departments to reach goals and objectives.
Inclusive with communication styles and ideas.
Conscientious to fellow peers with work load requirements.
Coordinate and lead weekly meetings with customers.
Fast and focused execution of tasks will be required at time.
Build helpful ideas to increase production efficiencies.
Technical skill information transferred to supporting departments.
Participate and support audit participation and interaction for regulatory agencies.
Develop and transform learning to peers with technical and mechanical result oriented aptitudes.
Written communication skills expected and presentation will be expected.
Equivalent combinations of education, training, and meaningful work experience may be considered.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically, manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Nice To Haves

Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred.
Project Management experience preferred

Responsibilities

Lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms.
Apply project management skills to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities.
Write, approve, and route documents within a manufacturing setting.
Be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives.
Support process development and commercial activities.
Lead technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations.
Investigate, creates, and validates new scientific and equipment methodologies for a diverse scope of projects.
Using experimental design, established formulation processes for the following phases of product scale-up, registration, and validation.
Create processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.
Lead problem solving activities as necessary with independent judgement.
Make decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems.
Coach Scientist I and Scientist II’s will be required to provide guidance on assigned projects.
Communicate up and down the internal management track to provide accurate and detailed progress of projects that focuses on timely completion of activities and critical turning points.
Leverage current leadership skills to provide support, mentoring and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas.
Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.
Own the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements.
Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies.
Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches.
Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility.
Lead with project leadership skill required for daily meetings
Manage work independently with standard work planning and abilities to meet timelines established for projects.